Corneal BlindnessNCT01950598
Frozen Versus Fresh Corneal Carriers for the Boston KPro Type I Donor Carriers
A study testing Boston KPro type I - fresh graft and Boston KPro type I surgery - frozen graft in people with Corneal Blindness and Boston Keratoprosthesis Type I Candidate, run by Marie-Claude Robert at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether frozen corneas are as safe and effective as fresh corneas for use as carriers with the Boston Keratoprosthesis type I (KPro) over long term follow-up. Corneal transplantation is typically performed using fresh, transparent corneas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Blindness, Boston Keratoprosthesis Type I Candidate
- What is being tested?
- Boston KPro type I - fresh graft and Boston KPro type I surgery - frozen graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subject over age 18 years
- Boston KPro type I indicated
- history, slit-lamp findings and B-scan do not suggest endstage glaucoma or significant posterior segment disease
- Able to provide informed consent for study inclusion
- Sufficiently healthy to undergo surgery and a vigorous post-operative follow-up course
- Able to administer eye medications or have a care-giver able and willing to do the same
- Corneal blindness with poor prognosis for survival of a traditional penetrating keratoplasty
Who cannot join
- Subject under age 18 years
- History, slit-lamp findings and B-scan suggest endstage glaucoma or significant posterior segment disease
- Not sufficiently healthy to undergo surgery and a vigorous post-operative follow-up course
- Unable to administer eye medication or does not have a care-giver willing to do the same
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 4M1
About this study
Official title: Boston Keratoprosthesis Type 1 Surgery: Use of Frozen Versus Fresh Corneal Donor Carriers
The purpose of this study is to determine whether frozen corneas are as safe and effective as fresh corneas for use as carriers with the Boston Keratoprosthesis type I (KPro) over long term follow-up.
Corneal transplantation is typically performed using fresh, transparent corneas. With KPro surgery, the corneal transplant only serves as a carrier to suture the KPro in place. The cornea used in KPro surgery does not need to be clear like a normal transplant. Frozen corneal tissue can be used to repair the cornea in cases of emergency but the tissue is not transparent and does not allow good vision. We hypothesize that frozen grafts are equivalent as fresh grafts when used as carrier for the KPro.
Read the detailed description
The Boston Keratoprosthesis (KPro) is a collar-button shaped device made from a specialized clear plastic material. This device is used to replace a diseased and opaque cornea with a clear window so that vision can be improved. KPro surgery is an alternative to a traditional corneal graft and is used when a traditional corneal graft has failed or has a very poor probability of success.
During KPro surgery, the KPro needs to be incorporated into a corneal graft before it is sutured to the patient's cornea. The corneal graft serves as a support to the KPro and helps to re-establish vision. The corneas typically used as carriers for the KPro are fresh corneas provided through donors. These fresh corneas are also used in traditional corneal transplantation, without KPro implantation.
Due to shortage of fresh corneas in the province of Quebec, this project is interested in evaluating if corneas that have been previously frozen can act as carriers to the KPro. The frozen corneas cannot be used in traditional corneal transplantation surgery because they are not transparent. However, they can act as a support to the KPro, as in this case, it is the KPro and not the corneal graft that re-establishes vision. The use of frozen corneas for KPro surgery has the potential to improve access to corneal donor tissue and improve the wait-times for KPro surgery.
37 patients were be recruited from the Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital between October 2008 and November 2009. Participants were divided into 2 groups: the first group will receive a KPro in a fresh corneal carrier graft while the second group will receive a KPro in a frozen carrier graft. The use of a fresh or frozen corneal graft depended on the availability of fresh tissue on the morning of surgery. 19 patients received a fresh carrier graft and 18 received a frozen carrier graft.
Patients were followed on postoperative day 1, week 1 and 2, month 1, 3 and 6 and every 1 to 3 months thereafter up to 2 years. At each follow-up visit, a complete ophthalmological examination was performed, including best-corrected Snellen visual acuity and slit lamp assessment for leaks, tissue necrosis, melts, extrusion, inflammation, retroprosthetic membrane formation and infectious endophthalmitis.
The current study aims re-consent patients previously enrolled in this study to prospectively evaluate the long-term outcomes of KPro surgery using either a fresh or frozen carrier graft. IRB approval was obtained from the CHUM. Written informed consent from the concerned patients will be obtained for this extension study during their routine visits at the CHUM Ophthalmology department.
Patients in this study will continue their routine follow-up at the frequency determined by their surgeon, which may vary from every 3 to 6 months.
Outcome measures include surgical feasibility, level of preoperative and postoperative visual acuity (VA), retention of the device and complications as stated above. Outcomes will be compared at 5 and 10 years.
- Being tested
- Boston KPro type I - fresh graft, Boston KPro type I surgery - frozen graft
- Keywords
- Boston Keratoprosthesis type I surgery, frozen corneal graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston KPro type I - fresh graftProcedure or surgery
Boston KPro mounted on fresh corneal carrier graft for implantation
Boston KPro type I surgery - frozen graftProcedure or surgery
Boston KPro mounted on frozen corneal carrier graft for implantation
| Study group | Role | What they receive |
|---|---|---|
| Fresh carrier graft for KPro | Active comparator | KPro implanted using fresh cornea, preserved in optisol GS Receives: Procedure: Boston KPro type I - fresh graft |
| Frozen carrier graft for KPro | Experimental | KPro implanted using frozen cornea, which was supplied as a whole globe cryopreserved at -80°C in gramicidin 0.025 mg/mL and polymyxin B sulfate 10 000 U/mL ophthalmic solution. Receives: Procedure: Boston KPro type I surgery - frozen graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extrusion rate
Measured: 10 years post-KPro implantation
Secondary outcomes (5)
Best-corrected visual acuity
Measured: 10 years
Retroprosthetic membrane formation
Measured: 10 years
Endophthalmitis rate
Measured: 10 years
Sterile vitritis rate
Measured: 10 years
Intraoperative complications
Measured: time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal BlindnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie-Claude Robert
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de recherche en ophtalmologie de l'Université de Montréal
- Responsible party
- Sponsor-investigator, Marie-Claude Robert, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- Mona Harissi-Dagher, M.D., Principal investigator, CHUM - Hôpital Notre-Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950598
- Sponsor's protocol ID
- FvF 08.275
- Status last verified
- Jan 2021
- First submitted
- 9 Sep 2013
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Robert MC, Biernacki K, Harissi-Dagher M. Boston keratoprosthesis type 1 surgery: use of frozen versus fresh corneal donor carriers. Cornea. 2012 Apr;31(4):339-45. doi: 10.1097/ICO.0b013e31823e6110.
PubMed 22269678
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boston Keratoprosthesis Type 1 Surgery: Use of Frozen Versus Fresh Corneal Donor Carriers
- ClinicalTrials.gov ID
- NCT01950598
- Acronym / sponsor ID
- FvF 08.275
- Keywords
- Boston Keratoprosthesis type I surgery, frozen corneal graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Marie-Claude RobertUniversity, hospital or other
- Collaborators
- Fonds de recherche en ophtalmologie de l'Université de Montréal
- Study start
- Sep 2013 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether frozen corneas are as safe and effective as fresh corneas for use as carriers with the Boston Keratoprosthesis type I (KPro) over long term follow-up.
Corneal transplantation is typically performed using fresh, transparent corneas. With KPro surgery, the corneal transplant only serves as a carrier to suture the KPro in place. The cornea used in KPro surgery does not need to be clear like a normal transplant. Frozen corneal tissue can be used to repair the cornea in cases of emergency but the tissue is not transparent and does not allow good vision. We hypothesize that frozen grafts are equivalent as fresh grafts when used as carrier for the KPro.
Detailed description
The Boston Keratoprosthesis (KPro) is a collar-button shaped device made from a specialized clear plastic material. This device is used to replace a diseased and opaque cornea with a clear window so that vision can be improved. KPro surgery is an alternative to a traditional corneal graft and is used when a traditional corneal graft has failed or has a very poor probability of success.
During KPro surgery, the KPro needs to be incorporated into a corneal graft before it is sutured to the patient's cornea. The corneal graft serves as a support to the KPro and helps to re-establish vision. The corneas typically used as carriers for the KPro are fresh corneas provided through donors. These fresh corneas are also used in traditional corneal transplantation, without KPro implantation.
Due to shortage of fresh corneas in the province of Quebec, this project is interested in evaluating if corneas that have been previously frozen can act as carriers to the KPro. The frozen corneas cannot be used in traditional corneal transplantation surgery because they are not transparent. However, they can act as a support to the KPro, as in this case, it is the KPro and not the corneal graft that re-establishes vision. The use of frozen corneas for KPro surgery has the potential to improve access to corneal donor tissue and improve the wait-times for KPro surgery.
37 patients were be recruited from the Centre Hospitalier de l'Université de Montréal (CHUM), Notre-Dame Hospital between October 2008 and November 2009. Participants were divided into 2 groups: the first group will receive a KPro in a fresh corneal carrier graft while the second group will receive a KPro in a frozen carrier graft. The use of a fresh or frozen corneal graft depended on the availability of fresh tissue on the morning of surgery. 19 patients received a fresh carrier graft and 18 received a frozen carrier graft.
Patients were followed on postoperative day 1, week 1 and 2, month 1, 3 and 6 and every 1 to 3 months thereafter up to 2 years. At each follow-up visit, a complete ophthalmological examination was performed, including best-corrected Snellen visual acuity and slit lamp assessment for leaks, tissue necrosis, melts, extrusion, inflammation, retroprosthetic membrane formation and infectious endophthalmitis.
The current study aims re-consent patients previously enrolled in this study to prospectively evaluate the long-term outcomes of KPro surgery using either a fresh or frozen carrier graft. IRB approval was obtained from the CHUM. Written informed consent from the concerned patients will be obtained for this extension study during their routine visits at the CHUM Ophthalmology department.
Patients in this study will continue their routine follow-up at the frequency determined by their surgeon, which may vary from every 3 to 6 months.
Outcome measures include surgical feasibility, level of preoperative and postoperative visual acuity (VA), retention of the device and complications as stated above. Outcomes will be compared at 5 and 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh carrier graft for KPro | Active comparator | Procedure: Boston KPro type I - fresh graftKPro implanted using fresh cornea, preserved in optisol GS |
| Frozen carrier graft for KPro | Experimental | Procedure: Boston KPro type I surgery - frozen graftKPro implanted using frozen cornea, which was supplied as a whole globe cryopreserved at -80°C in gramicidin 0.025 mg/mL and polymyxin B sulfate 10 000 U/mL ophthalmic solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult subject over age 18 years
- Boston KPro type I indicated
- history, slit-lamp findings and B-scan do not suggest endstage glaucoma or significant posterior segment disease
- Able to provide informed consent for study inclusion
- Sufficiently healthy to undergo surgery and a vigorous post-operative follow-up course
Key exclusion criteria (4 listed)
- Subject under age 18 years
- History, slit-lamp findings and B-scan suggest endstage glaucoma or significant posterior segment disease
- Not sufficiently healthy to undergo surgery and a vigorous post-operative follow-up course
- Unable to administer eye medication or does not have a care-giver willing to do the same
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boston KPro type I - fresh graftBoston KPro mounted on fresh corneal carrier graft for implantation | Procedure or surgery | Fresh carrier graft for KPro |
| Boston KPro type I surgery - frozen graftBoston KPro mounted on frozen corneal carrier graft for implantation | Procedure or surgery | Frozen carrier graft for KPro |
Primary outcome
Extrusion rate
Time frame: 10 years post-KPro implantation
5 secondary outcomes
Best-corrected visual acuity
Time frame: 10 years
Retroprosthetic membrane formation
Time frame: 10 years
Endophthalmitis rate
Time frame: 10 years
Sterile vitritis rate
Time frame: 10 years
Intraoperative complications
Time frame: time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Results publication: PubMed 22269678Robert MC, Biernacki K, Harissi-Dagher M. Boston keratoprosthesis type 1 surgery: use of frozen versus fresh corneal donor carriers. Cornea. 2012 Apr;31(4):339-45. doi: 10.1097/ICO.0b013e31823e6110.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Harissi-Dagher, M.D. principal investigator
CHUM - Hôpital Notre-Dame
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston KPro type I - fresh graft and Boston KPro type I surgery - frozen graft in people with Corneal Blindness and Boston Keratoprosthesis Type I Candidate, run by Marie-Claude Robert at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extrusion rate (time frame: 10 years post-KPro implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01950598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.